Package of reforms years in the making strengthens consumer protections

19 February 2018

Return to Media Release Index

The Australian Self Medication Industry (ASMI) has commended the passage of The Therapeutic Goods Bill (2017 Measure No.1), which enable a package of several important reforms that will strengthen protection for consumers.

These reforms include:

  • the expansion of the permitted indications (claims for and purpose of medicine) to be used with listed medicines
  • the establishment of an additional pathway for intermediate-risk medicines
  • stronger compliance and enforcement powers for the TGA; and
  • an amendment that extends the current arrangements for the pre-approval therapeutic goods advertisements until 30 June 2020. This replaces the original draft, in which the pre-approval system was to be replaced with a self-regulatory system.

Currently, product sponsors can access a pre-approval scheme that picks up errors and potential breaches of the Therapeutic Goods Advertising Code (TGAC) specifically and Therapeutic Goods legislation generally.

This system will continue to protect consumers from exposure to potentially false and misleading advertisements. It will also help medicines advertisers, publishers and broadcasters to ensure that advertisements comply with the Therapeutic Goods legislation.

The Bill will also provide the TGA with stronger compliance and enforcement powers, including graduated penalties for non-compliant behavior.

The postponement of the abolition of the pre-approval system will allow for the impact of new self-regulatory measures to be assessed after 18 months.

ASMI has already been working with our members and a range of stakeholders to develop a self-regulatory replacement system and we will continue to do so to ensure the success of the move to a self-regulatory service.

ASMI also supports the expansion of the permitted indications list.
"This will clean up the free text mechanism, which is where medicine sponsors make up their own indications," says ASMI CEO, Deon Schoombie.

"Now, if sponsors want to market products with stronger indications, they will have the option of using the new pathway for intermediate risk medicines."

"This is a huge improvement that provides industry with greater clarity."